Toxicology Services | Human Health Risk Assessment
Toxicology Assessment Services
Barkwith Associates provides specialist toxicology assessment and human health risk assessment services for chemicals, products and materials. Our expertise in regulatory toxicology, exposure assessment, chemistry and the interpretation of in chemico, in vitro and in vivo studies enables us to assess potential hazards and risks to human health.
We support clients throughout the product development and regulatory process, from toxicological data assessment and study design through to the interpretation of complex datasets and preparation of robust scientific assessments.
Human Health Risk Assessment
Understanding potential exposure to chemicals is essential when assessing risks to human health. Exposure can occur through food, drinking water, consumer products, household products, occupational environments and other routes.
Our human health risk assessment services combine expertise in toxicology, exposure assessment, chemistry and Adverse Outcome Pathways (AOPs) to evaluate potential risks associated with chemicals and products.
We assess available scientific and regulatory data to establish a robust understanding of potential hazards, exposure scenarios and health risks.
What is a Toxicology & Human Health Risk Assessment?
What is a toxicology assessment?
A toxicology assessment evaluates available scientific and regulatory information to determine the potential hazards and health effects associated with exposure to a chemical, substance or product. It considers toxicological studies, exposure information and relevant scientific evidence.
What is regulatory toxicology?
Regulatory toxicology is the application of toxicological science to support the assessment and regulation of chemicals, products and substances. It can involve the evaluation of regulatory studies, published scientific literature, exposure information and mechanistic data.
What is human health risk assessment?
Human health risk assessment evaluates the potential risk to people resulting from exposure to a chemical or substance. It considers factors including the toxicity of the substance, exposure levels, exposure routes and relevant toxicological data.
What toxicology studies can Barkwith Associates assess?
Barkwith Associates can support the design, monitoring, review and interpretation of in chemico, in vitro and in vivo toxicology studies, including liaison with Contract Research Organisations and review of study reports. This data is then integrated into the final product dossier prior to submission.
Can you support REACH toxicology assessments?
Yes. Toxicological data can form an important component of REACH registration and chemical safety assessment. Barkwith Associates can evaluate available toxicological evidence and help integrate it into wider regulatory assessments.
What is a toxicity profile?
A toxicity profile brings together available information about the potential harmful effects of a substance, including evidence from regulatory toxicology studies and published scientific literature. It can help establish the hazards associated with a substance and support subsequent risk assessment.
Toxicology Product Assessment Services
Human Health Risk Assessment
Understanding how people may be exposed to chemicals is fundamental to assessing potential risks to human health. Exposure can arise through a wide range of routes, including food, drinking water, consumer and household products, occupational environments and other sources.
Barkwith Associates supports clients in developing scientifically robust and regulator-ready human health assessment strategies for chemicals, biocides and plant protection products. We combine expertise in toxicology, exposure assessment, chemistry and regulatory science to assess hazards, exposure scenarios and potential risks to human health.
Our approach brings together the available scientific and regulatory evidence to provide a proportionate and scientifically justified assessment. This can include literature and systematic evidence reviews, data gap assessment, weight-of-evidence approaches, read-across and targeted testing strategies.
Where additional data are required, we help develop integrated testing strategies that address regulatory information requirements while seeking to avoid unnecessary testing. We place particular emphasis on the 3Rs principles — Replacement, Reduction and Refinement — and consider New Approach Methodologies (NAMs) and other scientifically appropriate non-animal approaches wherever possible.
Mode and Mechanism of Action
Understanding the mode and mechanism of action of a substance can provide important context when interpreting toxicological findings and determining their relevance to human health. Mechanistic information can complement conventional toxicity data and help provide a more complete understanding of how a substance interacts with biological systems.
At Barkwith Associates, we assess available mechanistic, toxicological and biological evidence to help establish how a substance may initiate or contribute to an adverse effect. This includes consideration of Adverse Outcome Pathways (AOPs) and other relevant mechanistic information.
Our expertise can be applied to complex toxicological questions, non-standard endpoints and situations where multiple lines of evidence need to be integrated. We can use mechanistic understanding to support weight-of-evidence assessments, read-across approaches and scientifically justified regulatory conclusions.
Where conventional testing may not fully address a regulatory question, we can also help develop targeted and integrated approaches incorporating NAMs, in vitro and in chemico methods and other relevant sources of mechanistic evidence.
Barkwith Associates can support assessments across a range of human health endpoints and regulatory requirements, including Sensitisation, Developmental and Reproductive Toxicity (DART), Developmental Neurotoxicity (DNT) and Endocrine Disruption (ED).
Our risk assessment expertise can encompass hazard classification and labelling, derivation of health-based reference values such as DNELs and AOELs, human exposure assessment, risk characterisation and risk management. We can also support the preparation and review of Safety Data Sheets (SDS) and the assessment and suitability of product labelling.
Toxicity Profiles and Toxicological Data Assessment
Our toxicologists review and critically evaluate toxicological data from regulatory studies and published scientific literature to develop clear, scientifically robust toxicity profiles and expert assessments.
Our experience includes supporting numerous successful chemical registrations and evaluating extensive regulatory and published toxicology data for a range of applications. This includes assessments relating to:
REACH registration and chemical safety assessment
Extractables and leachables
Exposure assessment
Human health risk assessment
Chemical contaminants
Regulatory toxicology and product safety
Endocrine disruptor potential
Toxicity and hazard characterisation
Weight-of-evidence evaluations
We can integrate information from multiple sources to provide a comprehensive understanding of the potential hazards and risks associated with a substance or product.
Toxicology Study Design, Monitoring and Interpretation
Well-designed toxicology studies and robust interpretation of the resulting data are central to an effective human health assessment. Barkwith Associates supports clients throughout the study lifecycle, from defining the scientific and regulatory objectives through to study placement, monitoring and interpretation of results.
Our expertise covers in chemico, in vitro and in vivo toxicological studies across both general and specialist toxicology. This includes systemic and local toxicity, genetic toxicology, developmental and reproductive toxicity, endocrine disruption, dermal toxicology and mechanistic toxicology.
We can help identify appropriate studies, address data gaps and develop testing programmes aligned with regulatory information requirements. Our specialists can support study design, test facility selection and liaison, study placement and independent monitoring, helping ensure that the resulting data are relevant, reliable and suitable for regulatory use.
Where appropriate, we consider weight-of-evidence, read-across and alternative testing approaches alongside conventional studies. This allows available evidence to be used effectively and can help minimise unnecessary testing and animal use while maintaining scientific and regulatory robustness.
Following completion of a study, we provide expert interpretation of the findings and their relevance to the wider toxicological dataset as well as offering dataset updates via IUCLID. This helps ensure that individual study results are considered in context and can contribute effectively to subsequent hazard and risk assessment.
Our services can include:
Selection and liaison with suitable Contract Research Organisations (CROs)
Review of interim and draft study reports
Review and development of study plans and protocols
Critical evaluation of toxicological findings
Scientific input during ongoing studies
Integration of findings into human health risk assessments
Liaison with laboratories and study directors
Interpretation of study results
Quality and compliance
The quality, reliability and regulatory relevance of toxicological data are essential when building a human health assessment or regulatory submission. Barkwith Associates provides independent oversight and scientific support to help ensure that studies are appropriately designed, conducted and interpreted, and that the resulting data are fit for their intended regulatory purpose.
We also consider the broader regulatory context when reviewing toxicological data, helping ensure that studies are relevant to current and anticipated regulatory requirements. This can support clients in responding to regulatory developments, compliance checks and substance evaluations, while identifying opportunities to address information requirements efficiently and avoid unnecessary testing.
We review study design, conduct and reporting against relevant regulatory guidelines and internationally recognised testing standards, including applicable OECD Test Guidelines and EPPO (European and Mediterranean Plant Protection Organization) standards, as appropriate to the study and regulatory context. Our approach also takes account of relevant regulatory guidance and information requirements applicable to chemicals, biocides and plant protection products.
Where appropriate, we also consider the 3Rs principles — Replacement, Reduction and Refinement — and the use of New Approach Methodologies (NAMs) and other scientifically appropriate approaches alongside established testing methods.
Our involvement can extend from initial study planning and protocol review through to study placement, monitoring and assessment of the final study report. We can work directly with testing facilities to monitor study progress, address issues as they arise and help maintain consistency across individual studies and wider testing programmes.
Our independent scientific and regulatory perspective helps ensure that toxicological datasets are robust, appropriately documented and suitable for integration into wider hazard and risk assessments and regulatory submissions.
Expert Toxicology Support for Regulatory Submissions
Toxicological data can form a critical part of regulatory submissions and product safety assessments. Our combination of scientific expertise and regulatory experience allows us to help clients interpret complex toxicological information and apply it effectively within the regulatory process.
Whether you require support with an individual toxicology study, a broader human health risk assessment or the evaluation of an extensive toxicological dataset, Barkwith Associates can provide tailored scientific and regulatory support.
Talk to us about your toxicology assessment requirements.
